Company insight
How pre-production services remove downstream obstacles
Mikron Automation, a leading provider of scalable and customisable automation solutions, offers a comprehensive suite of pre-production services designed to help manufacturers de-risk their programmes and accelerate their progress through the manufacturing design phase.
manufacturer has created a strong product concept, the next – and often most challenging – step is determining how to produce it efficiently and reliably. In an industry characterised by strict regulatory requirements and growing product complexity, moving from concept to manufacturing can be a demanding process that introduces risk, delays and unexpected costs.
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Manufacturers eager to bring innovations to market must work quickly to capture commercial opportunities. The key to accelerating commercialisation without compromising quality is to optimise product design for manufacturability and automated assembly as early as possible. Addressing potential issues up front prevents costly redesigns and helps ensure a smoother path to full-scale production. Mikron’s pre-production services were developed specifically to support this need By helping medical device manufacturers identify, analyse and mitigate production risks before manufacturing begins, these services enable a faster, more predictable transition to commercial-scale output. When a device is well designed for high- speed automation from the start, downstream obstacles become far less likely.
What are pre-production services? These services can take the form of quick guidance, targeted technical evaluations or a fully integrated engagement supporting every aspect of manufacturing readiness. Core elements of Mikron’s pre- production services include: ■
design for manufacturing (DFM) and design for assembly (DFA) analyses
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process failure mode and effects analysis (PFMEA)
process range and capability studies
www.medicaldevice-developments.com nce a medical device ■
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proof-of-principle and feasibility evaluations
prototype component builds process characterisation
“Customers know their medical devices extremely well, but they may not be as familiar with the realities of industrial assembly and high-volume production,” explains Jean François Bauer, head of marketing at Mikron Automation. “Our role is to help them de-risk their programme so they can reach commercialisation more quickly and confidently.”
How the pre-production process works Typically, Mikron begins with a high-level risk assessment. The team reviews the customer’s device design, identifies critical assembly steps and evaluates where potential challenges may arise. Subject matter experts then provide clear recommendations on design adjustments, process changes or verification work that could improve manufacturability. There are many opportunities to optimise a medical device for automated assembly. Early in development is the ideal time to evaluate joining methods – such as ultrasonic or laser welding – which may be more reliable or efficient than adhesive bonding. In other cases, subtle adjustments to part geometry can make components easier to feed, orient or handle, improving both speed and consistency during assembly. This phase is also appropriate for conducting process characterisation, which identifies and quantifies variables that may affect yield or final product quality. Mikron’s specialists can design and perform experiments, analyse results and advise on the control strategies that will support robust,
high-volume manufacturing. Mikron further provides extensive validation support, including standard operating procedure (SOP) development, design of experiments (DOEs) and process development, as well as installation, operational and performance qualification. Engaging early with these services helps manufacturers build a stronger user requirement specification (URS) and reduce the likelihood of late-stage changes, delays or compliance issues.
A proven approach backed by decades of experience With 50 years of experience in high-speed assembly and manufacturing, Mikron Automation’s pre-production services are a way of leveraging that knowledge to help its customers during their product development phase.
“When we started pre-production services, we thought it would really help a lot of our newer customers that may not have a lot of history in medical devices,” says Bauer. “Now, we are helping those companies – but we’re also helping some of the largest medical device companies in the world, who need to accelerate and don’t have the bandwidth to do some of the design for manufacturing and design for assembly analysis.
“By leveraging its extensive experience,
Mikron’s suite of pre-production services enables the company to be a stronger partner for its customers,” Bauer explains. “We want to be more than just a provider of equipment; we want to be a true resource that helps our customers bring their medical devices to market faster and more successfully.” ●
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